PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. 75854-314-30Prenate Elite (R) PRENATAL VITAMINS-FILM-COATED TABLETS GLUTEN FREE Rx Only Dietary Supplement 30 Tablets. Prenate Elite Bottle Label.

PRECAUTIONS SECTION.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

STORAGE AND HANDLING SECTION.

Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F) [See USP Controlled Room Temperature.].

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

BOXED WARNING SECTION.

WARNING: Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: PRENATE ELITE (R) is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

DESCRIPTION: PRENATE ELITE (R) is white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with PN on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye). Prenate Elite Supplement Facts Panel.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not National Drug Code. Instead, Avion Pharmaceuticals has assigned product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

INACTIVE INGREDIENT SECTION.

OTHER INGREDIENTS: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Film Coating (Hypromellose, Titanium Dioxide,Triacetin).

INDICATIONS & USAGE SECTION.

INDICATIONS: PRENATE ELITE (R) is multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.